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Medical Equipment

Agent Import of Class I and Class II Medical Devices

November 5, 2024 12:27

2024-11-01

Rigid Gas Permeable (RGP) contact lenses, also known as OK lenses, are specially designed high - oxygen - permeable lenses. After wearing them for a period of time, the hydraulic pressure formed by the tear fluid between the lens and the cornea can change the shape of the cornea and temporarily reduce myopia. For Rigid Gas Permeable (RGP) contact lenses, the following are the applicable inspection standards, import document review requirements, and standardized declaration requirements:

EUs Revision of Energy Label Requirements for Electronic Devices Will Impact Exports of Tablets, etc.

2024-10-31

The market access process for medical devices in South Korea is relatively complex, involving multiple steps and the participation of multiple departments. This article will briefly introduce the certification and registration processes required for exporting medical devices to South Korea.

Certification Requirements and Process for Exporting Medical Devices to the EU

2024-10-31

The medical device industry is a vital sector globally, covering a wide range of medical fields including diagnosis, treatment, and rehabilitation. With the advancement of globalization, the export trade of medical devices has become increasingly frequent. The EU, as one of the worlds largest economies, has a huge demand for medical devices. However, exporting medical devices to the EU requires compliance with a series of certification requirements, which is a significant task for exporters.

Medical Devices Exported to Japan: Necessary Certifications and Precautions

2024-10-31

When exporting medical devices to Japan, manufacturers need to understand and comply with a series of complex regulations and procedures. This article provides a concise guide covering Japans medical device legislation and regulatory authorities, product definitions and classifications, market access procedures, marketing authorization holder management, quality systems, post-market surveillance, and clinical trials.

Certification Requirements and Procedures for Exporting Medical Devices to Australia

2024-10-31

Australia has a mature and large - scale public and private healthcare system, and the demand for medical devices is also very strong. However, to sell, import, or export medical devices in Australia, it is necessary to complete the registration review and obtain an access certificate in accordance with relevant regulations. This article will introduce this process in detail.

South Korea: Revises International Standards for Medical Device Exports

2024-10-31

On May 12, 2023, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a notice to make some revisions to the Medical Device Manufacturing and Quality Control Standards to make it more in line with international standards. The main contents of the revisions include:

Certifications and Precautions for Medical Devices Exported to Malaysia

2024-10-30

Exporting medical devices to Malaysia requires meeting some specific certifications and requirements. The following are the certifications and precautions for exporting medical devices to Malaysia:

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